ORL Kids Mouthwash recall (Signature Formulations, LLC)
DrugClass IIOngoing
Summary: Signature Formulations, LLC is recalling ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA. Reason: cGMP Deviations.
What is being recalled
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Why
cGMP Deviations
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
AZ only (states named: Arizona)
How to tell if yours is affected
Lot #: 250505P9, Exp. Date 05/27
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0252-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 8, 2025 |
| Reported | January 14, 2026 |
| Company | Signature Formulations, LLC |
| Company location | Phoenix, AZ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 570 bottles |
More recalls from Signature Formulations, LLC · all drug recalls · recalls from December 2025